Tissue removal device and method of use

ABSTRACT

A biopsy device for acquiring more than one tissue sample is disclosed. The biopsy device can have at least two tissue engaging elements, where at least one element contains a helical feature. A control mechanism can be used to spin an outer element relative to an internal element, resulting in transport of multiple tissue samples from the mass of tissue to an accessible collection chamber. The outer element may have a sharp distal end which may sever the samples from the mass of tissue. Samples may be stored sequentially in the collection chamber and be removed by the operator.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of PCT InternationalApplication No. PCT/US 2011/061089 filed Nov. 16, 2011, which claims thebenefit of U.S. Provisional Application No. 61/415,850 filed Nov. 21,2010, which are both incorporated by reference herein in theirentireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to medical instrumentation. More particularly, atool used for acquiring tissue and a method for using the same aredisclosed.

2. Description of the Prior Art

A number of medical procedures require the removal of tissue samplesfrom a patient. These operations can range from the removal ofsuspicious tissue, as in the biopsy of a cancerous lesion, to cellharvesting, as in a bone marrow donation. A number of different biopsytools are used for retrieving these tissue samples from patients,falling into two broad categories: Single-Insertion, Single-Sample(SISS) tools and Single-Insertion, Multiple-Sample (SIMS) tools. With anSISS tool, the operator (1) positions the tool; (2) actuates thecollection mechanism(s); (3) removes the tool from the patient; (4)removes the sample from the tool; (5) prepares the tool forre-insertion; and (6) inserts the tool into the patient again. Thisprocedure, which may be repeated several times, is time-consuming andtraumatic for the patient. SIMS tools can eliminate steps three throughsix, above.

The mechanisms of SIMS devices are generally more complex and expensiveto manufacture than SISS tools. In addition, they are often quite largedevices, as a tissue capturing element is often moved fully distally toobtain the sample, then fully proximally to store the tissue sample.Other known devices shorten the device by spiraling the tissue capturingelement in the handle. Other known devices use tissue augers totransport the tissue, but these have not yet been employed in a systemthat can provide large contiguous samples.

Helical, tissue-contacting features can serve many functions in a biopsytool, from tissue securing to tissue storage. However, an auger systemhas not yet been employed in a low-cost, easy to use SIMS tool.Moreover, known devices require the internal element to rotate, whichtypically yields poor sample quality as the internal element must besufficiently large to transmit the required torque.

SUMMARY OF THE INVENTION

A tool used to obtain multiple tissue samples is disclosed herein. Themechanical transport system of the tool can be comprised of at least twoelements engaged with a tissue sample, where at least one of theelements can have a helical feature. Features can be separate elementsor shapes or configurations on existing elements. As the outer elementrotates, the outer element may core a section of tissue. Additionally,as the elements rotate with respect to each other, the tissue samplescan be urged proximally into a collection area where the tissue samplesmay be deposited, stored, viewed and retrieved.

The outer element can be a spinning transport tube with a sharpeneddistal edge and may have tissue-engaging features on the internal faceof the transport tube. Surface features can include tissue engagingfeatures which may include the internal surface of the transport tube,axially-oriented ribs, spiral or helical ribs, rifling of the tube, anoverlapping tube, a ribbon, surface coating, surface texturing, knurlingor combinations thereof. These features may be continuous ordiscontinuous. The internal surface of the transport tube may be smoothwith no features. A stationary internal element can be located withinthe transport tube. The internal element may have a helical geometry.The internal element may have a surface coating or texture which canengage with the tissue sample. The surface coating may be lubricious. Asthe outer element spins and is advanced into the tissue, the distal edgeof the transport tube may core a section of tissue. The tissue samplecan engage and spin with the internal surface features of the transporttube prior, concurrently, simultaneously, subsequently or anycombination thereof to the tissue sample being removed from the tissuemass from which the tissue sample is being separated. The tissue samplecan spin at the same angular velocity as the outer element (i.e.,rotationally stationary relative to the outer element) or at a fractionof the angular velocity of the outer element. The sample can be incontact with the internal element. As the sample spins relative to theinternal element, the screw-action (i.e., the rotation of the tissuesample against the helical geometry of the rotationally-fixed internalelement) may urge the sample proximally into a collection chamber. Thecollection chamber may be a portion of the outer element or may be aseparate element. The contents of the collection chamber may beaccessible to the operator at any time. The collected samples may bestored in the sequence of the acquisition of the samples. The tube, orouter element, can be transparent or translucent. The tube can have asection that can be transparent, translucent or open. The sample may beviewed through the tube.

The samples can be stored in a collection chamber. The entire chamber ora section of the chamber may be transparent, translucent, or open. Thesamples can be removed by cutting the tube or chamber. The chamber maybe always open to the atmosphere or have a protective covering which maybe moved to provide access to the samples. The collection chamber or aremovable bladder in the reservoir of the collection chamber maydissolve when exposed to a liquid, such as formalin. For example, thecollection chamber or the bladder can be made from wax, urate or uratecrystals.

The internal element may be removed from the device. The internalelement may be removed to provide a larger pathway within the tube. Theinternal element may be removed to access any samples that may beretained on the internal element. The internal element may be replacedwith a different helical element or tool.

The device may be used with a coaxial introducer. Prior to sampling, thecoaxial introducer and trocar may be positioned adjacent to the lesionand then the biopsy tool may be introduced through the coaxialintroducer. The biopsy tool may be secured to the coaxial introducer,such as with a luer connection.

The tissue samples may be rotationally stationary, or nearlyrotationally stationary, relative to the internal element. A spinningouter element may be composed of at least a transport tube. Thetransport tube can have a sharp distal edge and a spiral feature on theinternal face. Nested within the transport tube, the internal elementcan be a stationary wire with a rectangular cross-section which canpierce the tissue. As the transport tube spins and is advanced into thetissue, the transport tube may core a section of tissue. The internalelement can prevent rotation of the sample relative to the internalelement without restricting axial motion of the tissue sample. As thespiral feature on the outer element spins relative to the tissue sample,the spiral feature can force the sample proximally into a collectionchamber.

The tissue transport systems described above may be used in aside-cutting tool. For instance, a stationary tube may have a closeddistal end functioning as a trocar. Proximal to the closed end may be awindow cut into the wall of the tube that could allow passage of tissuesamples into the inner lumen. A second transport tube may be placedconcentrically inside the stationary tube, such that the radial gapbetween them is less than about 0.1 mm (0.005 in), but large enough suchthat the second transport tube and the stationary tube can move freelyrelative to each other. The internal transport tube may be actuatedforward or backward to control movement of tissue through the window. Avacuum may be applied to draw tissue through the window. The actuationof the internal transport tube to close the window may sever any tissuefrom the mass of tissue that has passed through the window. A tissuetransport system, as described herein, could then transport the samplesproximally, where the internal transport tube may be spun relative to athird internal element.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustrative isometric view of a variation of the tool.

FIG. 2 is an illustrative isometric view of the tool in FIG. 1 with anillustrative cutout in a transport tube, showing a helical elementlocated inside and a sample being transported proximally.

FIG. 3 illustrates a drive mechanism for the tool illustrated in FIG. 1and FIG. 2.

FIG. 4 a and FIG. 4 b illustrate variations of the helical element usedin the tool.

FIG. 5 a, FIG. 5 b and FIG. 5 c illustrate a side view of the distal endof the device being used to core and transport a tissue sample. Thespinning transport tube has been shown in cross-section.

FIG. 6 illustrates a second sample being deposited in the collectionchamber of the device. The device also has a coaxial introducer securedto the distal end of the handle.

FIG. 7 illustrates a coaxial introducer which may be used in conjunctionwith the device.

FIG. 8 illustrates a side-view of the distal end of the devicetransporting a sample proximally. The spinning transport tube is shownin cross-section.

FIG. 9 is an isometric view of the distal end of the transport tube,illustrating internal surface features of the element.

FIG. 10 is a transparent side view of the distal end of the transporttube, illustrating internal surface features of the element.

FIG. 11 is a side view of the distal end of the tool illustrating alancet-like tip.

FIG. 12 is a side view of the distal end of the tool illustrating awaved tip geometry.

FIG. 13 is a side view of the distal end of the tool illustrating astepped tip geometry

FIG. 14 a, FIG. 14 b and FIG. 14 c illustrate a method for removing theinner element from the device.

FIG. 15 is a side view of the distal end of a variation of the innerelement.

FIG. 16 a is a side view of the distal end of a variation of the innerelement.

FIG. 16 b is a proximal facing view of the design illustrated in FIG. 16a.

FIG. 16 c is a proximal facing view of a variation of the inner element.

FIG. 16 d is a proximal facing view of the design illustrated in FIG. 16b assembled with the transport tube and transporting a tissue sample.

FIG. 16 e is a proximal facing view of the design illustrated in FIG. 16c assembled with the transport tube and transporting a tissue sample.

FIG. 17 is a side view of the distal end of a trocar which may be usedin conjunction with the device.

FIG. 18 is a side view of the distal end of the device, where thestorage chamber is integrated within the transport tube. The transporttube is shown in cross-section.

FIG. 19 a and FIG. 19 b illustrate an isometric view of the distal endof a side-cutting variation of the tool. FIG. 19 a illustrates the toolconfigured to accept tissue. FIG. 19 b illustrates the tool configuredfor insertion or tissue-transporting.

FIG. 20 is a proximal facing view of the transport tube and helicalelement.

FIG. 21 a, FIG. 21 b and FIG. 21 c are transparent side viewsillustrating variations of the distal end of the transport tube.

FIGS. 22 a through 22 d are variations of cross-section A-A of FIG. 21a.

FIG. 22 e is an isometric view of a variation of the distal end of thetransport tube.

FIG. 22 f is a side view of a variation of the distal end of thetransport tube.

FIG. 22 g is a variation of cross-section B-B of FIG. 22 f.

FIG. 23 a and FIG. 23 b illustrate a tissue sample. FIG. 23 a is a sideview of a tissue sample and FIG. 23 b is a cross-section C-C of FIG. 23a.

FIG. 24 a is an isometric view of the distal end of the transport tube.

FIG. 24 b is a transparent isometric view of the distal end of the innerlumen.

DETAILED DESCRIPTION

FIG. 1 illustrates a tool 5. The tool 5 may be sterilized. The tool 5may have a handle 6 and a tissue transport system 7. The handle 6 canhave a handle top portion 14 and a handle bottom portion 16, or a handleleft portion and a handle right portion. The handle top portion 14 andhandle bottom portion 16 may be joined together to form an ergonomichandle which the operator may hold. The handle top portion 14 and handlebottom portion 16 may be injection molded. The tissue transport system 7can have a tissue-engaging first external outer element and atissue-engaging second internal inner element. The tissue-engaging firstelement (e.g., a tissue-engaging outer element) can be radially outsideof the tissue-engaging second element (e.g., a tissue-engaging innerelement). The tissue-engaging first element can be or have a transporttube 10. The tissue-engaging inner element can be or have a coiledhelical element 32, spiral element 74, flat stationary element 78,curved stationary element 86, or combinations thereof. The coiledhelical element 32 can be greater than about 50%, more narrowly greaterthan about 75%, yet more narrowly greater than or equal to about 100% ofthe length of a lumen of the transport tube 10. The transport tube 10can be rotatable or rotationally-fixed with respect to the handle 6. Thetransport tube 10 can extend distally from the handle 6 and can have aterminal distal end 12. The transport tube 10 may rotate or spin aboutan axis 8 in a direction 9. The handle 6 can have an electricalconnection 18 which can connect with an external power supply. The tool5 could instead, or in combination with an external power supply, bepowered with internal batteries, mechanically, hydraulically orpneumatically. A cover 20 may enclose the samples in a collectionchamber 26, shown in FIG. 2. The cover 20 may be removed or adjusted toprovide physical access to the samples stored in the collection chamber26. The cover 20 can be transparent. The rotation of the transport tube10 may be controlled by actuating a button 22. A first groove 24 can beused to secure a flexible sheath, for example, that can be used toisolate the sterile field from a power cord. The flexible sheath may be,for example, a 0.05 mm (0.002 in) thick open topped, cut-to-lengthpolyethylene bag.

FIG. 2 illustrates that the tool 5 can have a tissue-engaging secondelement, such as the helical element 32. The helical element 32 can berotatable or rotationally-fixed with respect to the handle 6. Thehelical element 32 and the transport tube 10 can transport a sample 11(e.g., a tissue) proximally in a direction 35. The cover 20 can beopened or removed, for example, to access the collection chamber 26. InFIG. 2, the cover 20 is not shown. The helical element 32 may extend towithin about ±3 mm (±0.12 in) of the distal end 12 of the transport tube10. The handle may also feature a handle connector 28. The handleconnector 28 may be formed by the handle top portion 14, handle bottomportion 16, or any combination thereof. The handle connector 28, whichmay be a luer fitting, may be used to secure other components to thetool, such as a coaxial introducer. The proximal end of the helicalelement 32 may feature an arm 33. The handle 6 can have a second groove30 that can be formed between or across the handle top and bottomportions 14, 16 or within one portion 14 or 16, individually. The arm 33may be secured to the handle 6 by wedging or friction fitting the arm 33into the second groove 30. The arm 33 can be longitudinally interferencefit into the second groove 30. The arm 33 may be secured to the handleby the cover 20. The arm 33 may be secured to the cover 20. The sample11 can be forced and transported proximally in the direction 35 alongthe inside of the transport tube 10, from the distal end 12 towards thecollection chamber 26. The sample 11 may be obtained, transported,deposited into the collection chamber 26, or combinations thereof, withor without applying suction to the proximal end of the transport tube 10or collection chamber 26. The sample 11 may be obtained, transported,deposited into the collection chamber 26, or combinations thereof,without or with a pressure differential between the terminal distal end12 and a proximal open port 53. For example biological pressure fromlungs or vessels at the terminal end of the transport tube 10 can exerta higher pressure than the external environment in fluid communicationwith the proximal end of the transport tube, for example pushing thetissue sample proximally in the transport tube.

FIG. 3 shows a drive system which may be used to spin the transport tube10. A motor 34 can spin when the button 22 is actuated. The motor 34 maybe powered by electricity. The motor 34 can be a DC brushed motor. Themotor 34 may be driven pneumatically, hydraulically, mechanically or anycombination thereof. A first pulley 36 may be secured to a motor shaft37. The first pulley 36 may be a timing belt pulley with a pitch ofabout 2 mm (0.08 in). The first pulley 36 may transmit torque to asecond pulley 38 via a timing belt 40. The first and second pulleys 36and 38 may be different sizes. The pulley 38 may be secured to thetransport tube 10.

FIG. 4 a shows that the helical element 32 may have a pitch 42 that isconstant along the length of the helical element 32. The pitch 42 of thehelical element 32 may be from about 7 mm (0.28 in.) to 20 mm (0.8 in.).The pitch 42 of the helical element may be specified for certainapplication, such as different tissue types. For example, the helicalelement 32 can be removed from the tool 5 and replaced with a secondhelical element 32 of a different configuration from the originalhelical element 32 (e.g., to be used in harder or softer tissue than theoriginal helical element 32 is intended to be used on). Configurationsof the helical element 32 may have a different pitch, wireform, surfacefeature, coating, cross-sectional shape, modulus of elasticity, orcombinations thereof. The wire used to form the helical element 32 mayhave a round cross-section. The helical element 32 can be made from wirewith a cross-section that is circular, angular, rectangular, triangularor combinations thereof (e.g., changing along the length of the wire).The helical element 32 may have a sharpened distal end 44. The helicalelement 32 may have the arm 33. The arm 33 may be used to secure thehelical element 32 to the handle 6. The arm 33 may hold the innerelement, such as the helical element 32, longitudinally stationaryrelative to the outer element, such as the transport tube 10. The arm 33may be used to manipulate (e.g., rotate and/or translate) the helicalelement 32, during manufacturing, assembly and use.

FIG. 4 b shows that the helical element 32 may have a varied pitch. Forexample, the helical element 32 may transition from a longer distalfirst pitch 43 to a shorter proximal second pitch 45. The distal pitch43 can be shorter than proximal pitch 45. An intermediate length betweenthe distal pitch 43 and the proximal pitch 45 can have a different pitchthan the proximal and distal sections (e.g., the distal pitch 43 can beequal to the proximal pitch 45 which can both be longer or shorter thanthe pitch of the intermediate length). The transition between firstpitch 43 and second pitch 45 may be smooth (e.g., continuouslytangential) or abrupt (e.g., discrete).

The pitch of the helical element (such as pitches 42, 43, 45 orcombinations thereof) may be larger than about 5 mm (0.20 in), yet morenarrowly larger than about 6 mm (0.24 in), yet more narrowly larger thanabout 7 mm (0.28 in), yet more narrowly larger than about 8 mm (0.31in), yet more narrowly larger than about 9 mm (0.35 in), yet morenarrowly larger than about 10 mm (0.39 in), yet more narrowly largerthan about 11 mm (0.43 in), yet more narrowly larger than about 12 mm(0.47 in), yet more narrowly larger than about 20 mm (0.8 in). The pitchof the helical element (such as pitches 42, 43, 45 or combinationsthereof) may be less than about 20 mm (0.8 in), yet more narrowly lessthan about 12 mm (0.47 in), yet more narrowly less than about 11 mm(0.43 in), yet more narrowly less than about 10 mm (0.39 in), yet morenarrowly less than about 9 mm (0.35 in), yet more narrowly less thanabout 8 mm (0.31 in), yet more narrowly less than about 7 mm (0.28 in),yet more narrowly less than about 6 mm (0.24 in), yet more narrowly lessthan about 5 mm (0.20 in).

The helical element 32 or any or all elements of the tool and/or othertools or apparatuses described herein can be made from or coated with,for example, single or multiple stainless steel alloys, steel, springsteel, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys(e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME®from Carpenter Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys(e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport,Conn.), molybdenum alloys (e.g., molybdenum TZM alloy), tungsten-rheniumalloys, polymers such as polyethylene teraphathalate (PET), polyester(e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington,Del.), polypropylene, aromatic polyesters, such as liquid crystalpolymers (e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultrahigh molecular weight polyethylene (i.e., extended chain, high-modulusor high-performance polyethylene) fiber and/or yarn (e.g., SPECTRA®Fiber and SPECTRA® Guard, from Honeywell International, Inc., MorrisTownship, N.J., or DYNEEMA® from Royal DSM N.V., Heerlen, theNetherlands), polytetrafluoroethylene (PTFE), Parylene polyp-xylylene)polymers, Parylene N, Parylene C, Parylene D, expanded PTFE (ePTFE),polyether ketone (PEK), polyether ether ketone (PEEK), polycarbonate(PC), Acrylonitrile Butadiene Styrene (ABS), poly ether ketone ketone(PEKK) (also poly aryl ether ketone ketone), nylon, polyether-blockco-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France),aliphatic polyether polyurethanes (e.g., TECOFLEX® from ThermedicsPolymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), Nylon,Vinyl, polyurethane, thermoplastic, fluorinated ethylene propylene(FEP), absorbable or resorbable polymers such as polyglycolic acid(PGA), poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lacticacid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA),polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extrudedcollagen, silicone, zinc, echogenic, radioactive, radiopaque materials,a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft,xenograft, bone cement, morselized bone, osteogenic powder, beads ofbone), a material with high strength (60 ksi) and biocompatibility, anyof the other materials listed herein or combinations thereof. Examplesof radiopaque materials are barium sulfate, zinc oxide, titanium,stainless steel, nickel-titanium alloys, tantalum and gold. The devicecan be made from substantially 100% PEEK, substantially 100% titanium ortitanium alloy, or combinations thereof.

FIG. 5 a, FIG. 5 b and FIG. 5 c illustrate a variation of a method forusing the tissue transport system 7. FIG. 5 a, FIG. 5 b and FIG. 5 cshow how the tool 5 may be manipulated to cut off a tissue sample from amass of tissue 48. The tissue mass may be located in a living or deadplant or animal, such as a tumor in a human breast. FIG. 5 a illustratesthat the transport tube 10 can be advanced (e.g., translated) relativeto and into the tissue 48 in a direction 47. The transport tube 10 canhave an open distal end 12. The transport tube 10 can receive a portionof the tissue 48 into a distal open port 31 at the distal end 12. Thetransport tube 10 can be rotated or spun relative to the tissue 48concurrent with being translated into the tissue 48. The transport tube10 can core the tissue 48. A tissue sample 11 can be a partially cored,severed or cut sample. The sample 11 may be in contact with the internalface and/or surface features of the transport tube 10. The sample 11 maystill be connected to the mass of tissue 48. The sample 11 cansimultaneously engage with the helical element 32 while being attachedto the mass of tissue 48 and in contact with the internal face and/orsurface features of the transport tube 10. The sample 11 can screw intothe helical element 32 as the transport tube 10 is rotated and advancedinto the mass of tissue 48.

FIG. 5 b shows that the transport tube 10 may be rotated in a direction49 to pinch the partially cored tissue sample 11 at a pinch point 52.While still attached to the mass of tissue 48, the portion of tissue inthe transport tube 10 can remain substantially rotationally fixed withrespect to the helical element 32. The terminal end of the distal end 12of the transport tube 10 can sever a tissue sample 11 from the mass oftissue 48. Alternatively or in addition to pinching, the sample 11 maybe severed from the mass of tissue 48 by continuing to spin thetransport tube 10 while not advancing the transport tube 10 distally, bycontinuing to spin the transport tube 10 while retreating the transporttube 10 proximally, by applying a lateral force on the tool 5 while thetransport tube 10 continues to spin or combinations thereof. Separationof the tissue sample 11 from the mass of tissue 48 and transportation ofthe sample 11 along the transport tube 10 can be atraumatic to thesample 11. For example, the sample 11 can be un-macerated, unsplit,maintain a contiguous cross-section, or combinations thereof.

FIG. 5 c shows that after the tissue sample 11 is detached or severedfrom the mass of tissue 48, continuing to spin the transport tube 10 maythen transport the tissue sample 11 proximally along the internal lengthof the transport tube 10, as shown. The tissue sample 11 may rotate orspin partially or completely with transport tube 10. The tissue sample11 may rotate or spin relative to the helical element 32. The relativerotational motion between the tissue sample 11 and the helical element32 may result in a forced translation of sample 11 in proximal direction51 along the longitudinal axis 8 of the transport tube 10.

FIG. 6 shows how the tissue samples collected in FIG. 5 a, FIG. 5 b andFIG. 5 c may be stored in the collection chamber 26. The tissuetransport system 7 can continue to advance the tissue sample 11 alongthe length of the transport tube 10 proximally as the tissue sample 11enters the collection chamber 26. As the tissue sample 11 emerges fromthe proximal open port 53 at the proximal end of the transport tube 10,the tissue sample 11 can enter and is delivered and deposited into thecollection chamber 26.

For example, a proximal tissue sample 11 a can exit the transport tube10 into the collection chamber 26. A distal tissue sample 11 b can becored and severed from the mass of tissue 48 after the proximal tissuesample 11 a is cored and severed from the mass of tissue 48. The distaltissue sample 11 b can be proximally advanced along the length of thetransport tube 10. The distal tissue sample 11 b can abut and push theproximal tissue sample 11 a in a proximal direction 55. The proximaltissue sample 11 b can be pushed completely out of the transport tube 10and into the collection chamber 26. The tissue samples 11 may be storedin the collection chamber 26 in chronological sequence of collection.After the tissue sample 11 emerges completely from the transport tube10, the tissue sample 11 can cease to move unless contacted by anexternal force, such as the motion of another tissue sample 11.

FIG. 6 illustrates that the tool 5 can include or be removably attachedto a coaxial introducer 54, such as Bard C1213B, manufactured by BardBiopsy Systems of Arizona. An introducer connector 60 on the coaxialintroducer 54 may be detachably secured to the handle 6 at handleconnector 28. The distal end 12 of the transport tube 10 may extend pastan introducer distal edge 56 of the coaxial introducer 54. The coaxialintroducer 54 may protect the mass of tissue 48 other than the sample 11from most or all of the transport tube 10. The coaxial introducer 54 mayprovide a bearing surface for the transport tube 10.

FIG. 7 shows that the coaxial introducer 54 can have an introducer tube58. The introducer tube 58 can fit over the transport tube 10. Theradial clearance between the introducer tube 58 and the transport tube10 may be larger than about 0.02 mm (0.001 in), more narrowly largerthan about 0.1 mm (0.004 in), yet more narrowly larger than about 0.2 mm(0.008 in), yet more narrowly larger than about 0.3 mm (0.012 in), oryet more narrowly larger than about 0.4 mm (0.015 in). The radialclearance between the introducer tube 58 and the transport tube 10 canbe smaller than about 0.4 mm (0.015 in), more narrowly smaller thanabout 0.3 mm (0.012 in), yet more narrowly smaller than about 0.2 mm(0.008 in), yet more narrowly smaller than about 0.1 mm (0.004 in), oryet more narrowly smaller than about 0.02 mm (0.001 in). The introducertube 58 may have the sharp introducer distal edge 56.

The coaxial introducer 54 may have the introducer connector 60. Theintroducer connector 60 may be a luer fitting and may mate with thehandle connector 28. The mating connectors 28 and 60 may be threaded ina direction that tightens the mating connection as the transport tube 10spins. The coaxial introducer 54 may be positioned in the tissue 48 witha sharp trocar 94 or stylet located within the introducer tube 58. Afterthe introducer distal edge 56 is placed adjacent to the target, thetrocar 94 may be removed and replaced with the tool 5. The coaxialintroducer 54 may be echogenic and have position markings to guide theoperator.

FIG. 8 illustrates that the helical element 32 may have a clearance fit61 with the transport tube 10. For example, the clearance fit 61 can belarge enough that the components can spin freely relative to each other.The clearance fit 61 can be larger than about 0.02 mm (0.001 in), morenarrowly larger than about 0.1 mm (0.004 in), yet more narrowly largerthan about 0.2 mm (0.008 in), yet more narrowly larger than about 0.3 mm(0.012 in), or yet more narrowly larger than about 0.4 mm (0.015 in).The clearance fit 61 can be smaller than about 0.4 mm (0.015 in), morenarrowly smaller than about 0.3 mm (0.012 in), yet more narrowly smallerthan about 0.2 mm (0.008 in), yet more narrowly smaller than about 0.1mm (0.004 in), or yet more narrowly smaller than about 0.02 mm (0.001in). The helical element 32 can urge a tissue sample 11 in a proximaldirection 63 as the tissue sample 11 spins relative to the helicalelement 32. The tissue sample 11 can be cored, severed, and transportedfrom the mass of tissue 48 to the collection chamber 26 quickly, such asin less than about 6 seconds, more narrowly in less than about 3seconds, for example to minimize trauma to both patient, the mass oftissue 48, and the tissue sample 11.

The distal end 44 of the helical element 32 may extend past the distalend 12 of the transport tube 10, as illustrated in FIG. 8. The distalend 44 may terminate flush (i.e., terminating at the same length) withthe distal end 12. The distal end 44 may terminate proximal to thedistal end 12. The distance between the distal ends 12 and 44 may belarger than about 0.5 mm (0.02 in), yet more narrowly larger than about1 mm (0.04 in), yet more narrowly larger than about 1.5 mm (0.06 in),yet more narrowly larger than about 2 mm (0.08 in), yet more narrowlythan about 2.5 mm (0.10 in), yet more narrowly larger than about 3 mm(0.12 in), yet more narrowly larger than about 3.5 mm (0.14 in), yetmore narrowly larger than about 4 mm (0.18 in), yet more narrowly largerthan about 4.5 mm (0.18 in), yet more narrowly larger than about 5 mm(0.20 in), yet more narrowly larger than about 6 mm (0.24 in), yet morenarrowly larger than about 7 mm (0.28 in). yet more narrowly larger thanabout 10 mm (0.39 in). The distance between the distal ends 12 and 44may be less than about 10 mm (0.39 in), yet more narrowly less thanabout 7 mm (0.28 in), yet more narrowly less than about 6 mm (0.24 in),yet more narrowly less than about 5 mm (0.20 in), yet more narrowly lessthan about 4.5 mm (0.18 in), yet more narrowly less than about 4 mm(0.18 in), yet more narrowly less than about 3.5 mm (0.14 in), yet morenarrowly less than about 3 mm (0.12 in), yet more narrowly less thanabout 2.5 mm (0.10 in), yet more narrowly less than about 2 mm (0.08in), yet more narrowly less than about 1.5 mm (0.06 in), yet morenarrowly less than about 1 mm (0.04 in), yet more narrowly less thanabout 0.5 mm (0.02 in).

During transport from the distal end 12 of the transport tube 10 to thecollection chamber 26, the tissue sample 11 can have a linear velocityof greater than about 1 cm/sec (0.4 in/sec), yet more narrowly largerthan about 2.5 cm/sec (1.0 in/sec), yet more narrowly larger than about5 cm/sec (1.9 in/sec), yet more narrowly larger than about 7.5 cm/sec(2.9 in/sec), or yet more narrowly larger than about 10 cm/sec (3.9in/sec). During transport from the distal end 12 of the transport tube10 to the collection chamber 26, the tissue sample 11 can have a linearvelocity of less than about 10 cm/sec (3.9 in/sec), yet more narrowlyless than about 7.5 cm/sec (2.9 in/sec), yet more narrowly less thanabout 5 cm/sec (1.9 in/sec), yet more narrowly less than about 2.5cm/sec (1.0 in/sec), or yet more narrowly less than about 1 cm/sec (0.4in/sec). The linear velocity of the sample may change along the lengthof the transport tube 10, for example if the helical element 32 has avarying pitch.

The transport tube 10 may spin or rotate at a velocity relative to thehandle 6 of greater than about 1,000 rpm, yet more narrowly larger thanabout 2,500 rpm, yet more narrowly larger than about 3,000 rpm, yet morenarrowly larger than about 4,000 rpm, yet more narrowly larger thanabout 5,000 rpm, yet more narrowly larger than about 7,500 rpm, yet morenarrowly larger than about 10,000 rpm. The transport tube 10 may spin orrotate at a velocity relative to the handle 6 of less than about 10,000rpm, yet more narrowly less than about 7,500 rpm, yet more narrowly lessthan about 5,000 rpm, yet more narrowly less than about 4,000 rpm, yetmore narrowly less than about 3,000 rpm, yet more narrowly less thanabout 2,500 rpm, yet more narrowly less than about 1,000 rpm.

The tissue-engaging first element may spin or rotate relative to thetissue-engaging second element at a relative velocity of greater thanabout 1,000 rpm, more narrowly larger than about 2,500 rpm, yet morenarrowly larger than about 3,000 rpm, yet more narrowly larger thanabout 4,000 rpm, yet more narrowly larger than about 5,000 rpm, yet morenarrowly larger than about 7,500 rpm, or yet more narrowly larger thanabout 10,000 rpm. The tissue-engaging first element may spin or rotaterelative to the tissue-engaging second element at a relative velocity ofless than about 10,000 rpm, more narrowly less than about 7,500 rpm, yetmore narrowly less than about 5,000 rpm, yet more narrowly less thanabout 4,000 rpm, yet more narrowly less than about 3,000 rpm, yet morenarrowly less than about 2,500 rpm, or yet more narrowly less than about1,000 rpm. The relative rotational speed between the tissue-engagingfirst element and the tissue-engaging second element may vary, forexample the relative rotational speed may be higher during tissue coringthan tissue transport.

The ratio of rotation of the tissue sample 11 to the transport tube 10may be greater than about 10% (e.g., the sample 11 may spin or rotate ata rate greater than about 10% of the rpm of the transport tube 10), morenarrowly greater than about 25%, yet more narrowly greater than about50%, yet more narrowly greater than about 75%, yet more narrowly greaterthan about 99% (e.g.—the sample 11 and the transport tube 10 arespinning together at approximately the same rate, with very littlerotational slippage). The ratio of rotation of sample 11 to thetransport tube 10 may be less than about 100% (e.g.—the sample 11 andthe transport tube 10 are spinning together at approximately the samerate, with very little rotational slippage), more narrowly less thanabout 75%, yet more narrowly less than about 50%, yet more narrowly lessthan about 25%, yet more narrowly less than about 10% (e.g., the sample11 may spin or rotate at a rate less than about 10% of the rpm of thetransport tube 10).

The coefficient of friction between the sample 11, the helical element32, the transport tube 10, tissue-engaging surface features or anycombination thereof may be greater than about 0.05, more narrowlygreater than about 0.1, yet more narrowly greater than about 0.2, yetmore narrowly greater than about 0.4, yet more narrowly greater thanabout 0.6, yet more narrowly greater than about 0.8, yet more narrowlygreater than about 1.0. The coefficient of friction between the sample11, the helical element 32, the transport tube 10, tissue-engagingsurface features or any combination thereof may be less than about 1.0,more narrowly less than about 0.8, yet more narrowly less than about0.6, yet more narrowly less than about 0.4, yet more narrowly less thanabout 0.2, yet more narrowly less than about 0.1, or yet more narrowlyless than about 0.05.

The internal diameter of the transport tube 10 may be larger than about0.5 mm (0.02 in), more narrowly larger than about 1 mm (0.04 in), yetmore narrowly larger than about 1.5 mm (0.06 in), yet more narrowlylarger than about 2 mm (0.08 in), yet more narrowly than about 2.5 mm(0.10 in), yet more narrowly larger than about 3 mm (0.12 in), yet morenarrowly larger than about 3.5 mm (0.14 in), yet more narrowly largerthan about 4 mm (0.18 in), yet more narrowly larger than about 4.5 mm(0.18 in), yet more narrowly larger than about 5 mm (0.20 in), yet morenarrowly larger than about 6 mm (0.24 in), yet more narrowly larger thanabout 7 mm (0.28 in), or yet more narrowly larger than about 10 mm (0.39in). The internal diameter of the transport tube 10 may be less thanabout 10 mm (0.39 in), more narrowly less than about 7 mm (0.28 in), yetmore narrowly less than about 6 mm (0.24 in), yet more narrowly lessthan about 5 mm (0.20 in), yet more narrowly less than about 4.5 mm(0.18 in), yet more narrowly less than about 4 mm (0.18 in), yet morenarrowly less than about 3.5 mm (0.14 in), yet more narrowly less thanabout 3 mm (0.12 in), yet more narrowly less than about 2.5 mm (0.10in), yet more narrowly less than about 2 mm (0.08 in), yet more narrowlyless than about 1.5 mm (0.06 in), yet more narrowly less than about 1 mm(0.04 in), or yet more narrowly less than about 0.5 mm (0.02 in).

The wall thickness of the transport tube 10 may be larger than about0.05 mm (0.002 in), more narrowly larger than about 0.10 mm (0.004 in),yet more narrowly larger than about 0.15 mm (0.006 in), yet morenarrowly larger than about 0.20 mm (0.008 in), yet more narrowly largerthan about 0.30 mm (0.012 in), yet more narrowly larger than about 0.50mm (0.020 in), yet more narrowly larger than about 0.70 mm (0.028 in),or yet more narrowly larger than about 1.00 mm (0.039 in). The wallthickness of the transport tube 10 may be less than about 1.00 mm (0.039in), yet more narrowly less than about 0.70 mm (0.028 in), yet morenarrowly less than about 0.50 mm (0.020 in), yet more narrowly less thanabout 0.43 mm (0.017 in), yet more narrowly less than about 0.30 mm(0.012 in), yet more narrowly less than about 0.20 mm (0.008 in), yetmore narrowly less than about 0.15 mm (0.006 in), yet more narrowly lessthan about 0.10 mm (0.004 in), or yet more narrowly less than about 0.05mm (0.002 in).

The wire thickness of the helical element 32 may be larger than about0.05 mm (0.002 in), more narrowly larger than about 0.10 mm (0.004 in),yet more narrowly larger than about 0.15 mm (0.006 in), yet morenarrowly larger than about 0.20 mm (0.008 in), yet more narrowly largerthan about 0.30 mm (0.012 in), yet more narrowly larger than about 0.50mm (0.020 in), yet more narrowly larger than about 0.70 mm (0.028 in),or yet more narrowly larger than about 1.00 mm (0.039 in). The wirethickness of the helical element 32 may be less than about 1.00 mm(0.039 in), more narrowly less than about 0.70 mm (0.028 in), yet morenarrowly less than about 0.50 mm (0.020 in), yet more narrowly less thanabout 0.30 mm (0.012 in), yet more narrowly less than about 0.20 mm(0.008 in), yet more narrowly less than about 0.15 mm (0.006 in), yetmore narrowly less than about 0.10 mm (0.004 in), or yet more narrowlyless than about 0.05 mm (0.002 in). The wire thickness can be about 0.4mm (0.016 in.), 0.43 mm (0.017 in.), or combinations thereof.

The tissue sample 11 can rotate none at all or almost none relative tothe non-helical element, such as the transport tube 10 in someconfigurations. The internal face of the transport tube 10 or any or allelements of the tool and/or other tools or apparatuses described hereincan have surface features. Surface features may include tissue engagingfeatures which can be one or more spiral and/or axial ribs, knurling,ridges, spines, barbs, coatings, textured surface, overlapping tubeand/or tubes, ribbon and/or ribbons, or combinations thereof. Surfacefeatures can be configured to engage or not engage the tissue. Thesurface features can be continuous or discontinuous along the surface(e.g., along a portion of the length, a portion of the arc of the wall,or combination thereof) of the tissue-engaging first and/or secondelements.

FIG. 9 illustrates that the inner surface of the transport tube 10 cancomprise one or more axially oriented rib 62. The rib 62 can increasetorsional traction (e.g., deliver rotational force) between the tissuesample 11 and the transport tube 10. The rib 62 may not significantlyimpact traction (e.g., delivering no longitudinal force and providingminimal or no counter force in the longitudinal direction) in thelongitudinal direction between the tissue sample 11 and the rib 62. Thetransport tube 10 may have one rib 62, more narrowly more than aboutfive ribs 62, yet more narrowly more than about ten ribs 62, yet morenarrowly more than about fifteen ribs 62. The transport tube 10 may haveabout twenty ribs 62, more narrowly less than about fifteen ribs 62, yetmore narrowly less than about ten ribs 62, yet more narrowly less thanabout five ribs 62. The rib 62 can be integrated with the transport tube10, such as by being formed by being machined, wire EDM, extruded orstamped from the same block of material, and/or separate elements whichcan be secured to the transport tube 10 with glue, welding, brazing,epoxy, one or more rivets, friction (e.g., crimping; or a springradially tightened to under a relaxed diameter of the spring which isthen released into the transport tube 10 having a diameter less than therelaxed diameter), or combinations thereof. The transport tube 10 can beabsent, for example, if the elements of the rib 62 are rigid, as in arigid coil. The rib 62 can be formed by removing material from thetransport tube 10. For instance, the rib 62 can be slots machined orrifled in the transport tube 10. The rib 62 may be formed by compressingthe transport tube 10, raising or stretching the surface of thetransport tube 10 (e.g., radially inwardly embossing or stamping acompliant material of the transport tube 10), removing material (e.g.,wire EDM, EDM, or machining) or any combination thereof.

FIG. 10. illustrates that the internal face of the transport tube 10 canhave spiral ribs 64 a and 64 b. The transport tube 10 can have onespiral rib 64 a, or multiple spiral ribs. The direction of the spiralribs 64 can be opposite that of the internal helical element 32 (e.g.,if the internal helical element 32 is oriented clockwise, then thespirals ribs 64 a and 64 b can be oriented counter-clockwise). Spiralrib distal ends 66 a and 66 b of the spiral ribs 64 a and 64 b,respectively, can be sharpened and extend past the tube body distal end12. The rib distal end 66 can extend distal to the tube body distal end12. The rib distal end 66 can be flush (i.e., terminating at the samelength) with the tube body distal end 12. The rib distal end 66 canterminate proximally to the tube body distal end 12. The distancebetween the terminal rib distal end 66 and the tube body distal end 12can be more than 0.2 mm (0.008 in), yet more narrowly more than 0.4 mm(0.016 in), yet more narrowly more than 0.6 mm (0.024 in), yet morenarrowly more than 0.8 mm (0.03 in), or yet more narrowly more than 1.0mm (0.04 in). The distance between the terminal distal end 66 and thedistal end 12 can be less than 1.0 mm (0.04 in), more narrowly less than0.8 mm (0.03 in), yet more narrowly less than 0.6 mm (0.024 in), yetmore narrowly less than 0.4 mm (0.016 in), or yet more narrowly lessthan 0.2 mm (0.008 in). The spiral rib distal ends 66 a and 66 b can besharp cutting elements, for example, to core the mass of tissue 48.

The distal end 12 of the transport tube 10 may have a bias grind, vetpoint, lancet point, deflected point, probe point, blunt end, trephine,menghini, razor edge surface, or combinations thereof. The distal end 12may have a sharpened non-planar profile, as shown in FIG. 11, FIG. 12and FIG. 13. For instance, FIG. 11 illustrates how the distal end 12 ofthe transport tube 10 can come to a sharp lancet-like point 68. The tool5 can be inserted into the mass of tissue 48 of the patient when atrocar is not used, or when a trocar is used. FIG. 12 shows that thedistal end 12 may have wave profile 70. FIG. 13 shows that the distalend 12 may have a stepped circumference with sharp edges 72.

FIG. 14 a, FIG. 14 b and FIG. 14 c illustrate how the helical element 32may be removed from the tool. During sample acquisition, the arm 33 maybe secured in the second groove 30. The arm 33 may be rotated in acounter-clockwise direction 71, for example to remove the helicalelement 32 from the groove 30. Subsequently, the helical element 32 maybe pulled proximally out of the transport tube 10 in a direction 73, forexample, until the helical element 32 is laterally unconstrained by thetransport tube 10 or the remainder of the tool 5, such as by thecollection chamber 26. A different helical element 32 (e.g., with adifferent pitch) or other element, such as spiral element 74, flatstationary element 78, curved stationary element 86, trocar 94, orcombinations thereof, can be inserted into the transport tube 10 in areverse of the method described in FIG. 14 a through FIG. 14 c.Similarly, any of the tissue-engaging second elements can be removedfrom the tissue-engaging first element and tool, and be replaced by thesame type or a different tissue-engaging second element.

FIG. 15 illustrates a close-up of a spiral element 74. The spiralelement 74 can have the same function of the helical element 32 in FIG.4 a. The spiral element 74 may pierce the tissue sample 11. The spiralelement 74 may have a smaller outside diameter than helical element 32.The spiral element 74 can be a twisted, flat wire or ribbon as shown inFIG. 15. A terminal distal tip 76 may be sharpened, for example, toallow the spiral element 74 to pierce the tissue 48. The pitch of thespiral element 74 may be similar to the pitches 42, 43, 45 orcombinations thereof. A portion of the spiral element 74 may beuntwisted, such as on the proximal and/or distal ends of the spiralelement 74.

FIG. 16 a shows that a flat stationary element 78 can be a straight flatwire or ribbon. The flat stationary element 78 can prevent the tissuesample 11 from spinning relative to the flat stationary element 78. Theflat stationary element 78 may be concentric with and/or off-axis fromthe transport tube 10 (e.g., the flat stationary element 78 may beconcentric with the transport tube 10 for a portion of the length). Theinternal face of the transport tube 10 can comprise a helical feature orelement, such as the spiral rib 64 shown in FIG. 10. As the transporttube 10 rotates relative to the flat stationary element 78 and thetissue sample 11, the tissue sample 11 can be urged proximally alongaxis 8. The flat stationary element 78 can have a sharpened tip 80. Thecross-section of the flat stationary element 78 may be rectangular, asshown in FIG. 16 b. For example, the thickness of a first side 82 may beabout 0.3 mm (0.01 in) and the width of a second side 84 may be about0.5 mm (0.02 in). The cross-section of the flat stationary element 78can be circular, angular, rectangular, triangular or combinationsthereof (e.g., changing along the length of the flat stationary element78).

FIG. 16 c illustrates that the stationary element may be a curvedstationary element 86. The curved stationary element 86 can have anouter surface 90. The outer surface 90 can contact and/or rest on theradially inner surface of the spiral rib 64, or any other surfacefeatures which can rotate relative to outer surface 90. The curvedstationary element 86 can have bends 88 a and 88 b extending at an angle(e.g., from about 45 degrees to about 135 degrees) from the outersurface 90. The bends 88 a and 88 b can engage with the tissue sample 11to prevent the tissue sample 11 from rotating relative to the curvedstationary element 86. The bends 88 a and 88 b can provide structuralrigidity to the curved stationary element 86. The curved stationaryelement 86 can have one bend 88 or multiple bends 88. The tissue sample11 may contact the inner surface 92.

FIG. 16 d illustrates that the stationary element (shown as flatstationary element 78) can be approximately centered in the transporttube 10. The stationary element may pierce the tissue sample 11. Thetissue sample 11 may be in contact with the transport tube 10, internalsurface features of the transport tube 10, or a combination thereof. Thetissue sample 11 may be in contact with spiral rib 64. The stationaryelement may be radially spaced (“off-axis”) away from axis 8 of thetransport tube 10.

FIG. 16 e illustrates that the curved stationary element 86 may bepositioned off-axis from the transport tube 10. The curved stationaryelement 86 may be centered or approximately centered with the transporttube 10. The curved stationary element 86 may surround the tissue sample11, the curved stationary element 86 may fully pierce the tissue sample11 or a combination thereof (e.g. the position of the curved stationaryelement 86 relative to the transport tube 10 may vary along the axis 8).The tissue sample 11 may be in contact with the transport tube 10,internal surface features, spiral rib 64 or a combination thereof.

FIG. 17 shows a trocar 94 that can be a sharp stylet. The trocar 94 canbe inserted into the coaxial introducer 54, for example before, and/orduring, and/or after the coaxial introducer is inserted into the tissue48. The trocar 94 can be removed from the coaxial introducer before thetransport tube 10 is inserted into the coaxial introducer 54.

The trocar 94 may be located in the transport tube 10 while the tool 5is inserted into the patient and into the tissue 48. The trocar 94 canbe removed from the tool 5 during sampling (e.g., coring, severing andtranslating the tissue sample 11 into the collection chamber 26). Thetrocar 94 can have a structural rod 96 with a sharpened distal end 100.The trocar 94 may be located adjacent to the tissue-engaging secondelement, such as concentrically within the helical element 32. Thetrocar 94 may replace the tissue-engaging second element duringinsertion of the tool 5 into the tissue 48 and be exchanged with thetissue-engaging second element prior to sampling. The trocar 94 can beadvanced along the axis 8, for example, by the rotation of the transporttube 10. The trocar 94 can have bumps 98 a and 98 b that can extendradially from the outer wall of the trocar 94. The trocar can be withoutbumps 98. The trocar 94 can be slid concentrically within the transporttube 10 and the helical element 32. The bumps 98 a and 98 b can engagewith the inner surface of the wall of the transport tube 10, with theradial inner surface of the outer element, with surface features of thetransport tube 10, with the internal features on the transport tube 10,such as the spiral rib 64, with the helical element 32, with theinternal element, with surface features of the helical element 32, orany combination thereof. The trocar 94 may be advanced or refractedalong the axis 8, for example, by pressing the button 22 to actuate themotor 34 clockwise or counterclockwise. The helical element 32 mayremain in the transport tube 10 when the trocar 94 is inserted in thetransport tube 10. For example, the helical element 32 can be positionedbetween the trocar 94 and the inner wall of the transport tube 10.

FIG. 18 illustrates that the transport tube 10 may store the tissuesamples 11 a and 11 b. The length of the portion of the tool 5 which isinside of the patient can be greater than about 7.5 cm (3 in). Thetissue samples 11 may travel at least about 7.5 cm (3 in) to reach thecollection chamber 26.

The transport tube 10 may have a transition portion, such as taper 108.The transition portion, such as taper 108, can connect a sample-motilitylength at the distal end of the tube 10 with a sample-storage length atthe proximal end of the tube 10. The sample-motility length can have asmaller diameter distal section 104, high-friction tube section,lower-friction tissue-engaging second element section, surface-featuredsection, thicker tissue-engaging second element section, or combinationsthereof. The sample-storage length can have a larger diameter proximalsection 106, a lower-friction tube section, a higher-friction tissueengaging second element section, a section absent of or having minimalsurface features, a thinner tissue-engaging second element section, orcombinations thereof.

The smaller diameter distal section 104 can be about 2.5 cm (1 in) inlength. A tissue sample, such as the third tissue sample 11 c, as shown,can be in contact with both the helical element 32 and the transporttube 10 while in the smaller diameter distal section 104. The tissuesample 11 can be cored and transported proximally in a direction 105along the smaller diameter distal section 104 until the tissue sample 11passes the taper 108.

In the larger diameter proximal section 106, the tissue samples, such asthe first and second tissue samples 11 a and 11 b as shown, may cease tocontact the tube 10 and thus cease to rotate with the tube 10. In thelarger diameter proximal section 106, the tissue samples 11 may cease torotate with respect to the helical element 32. As the tool 5 acquiresmore tissue samples 11, the newly acquired tissue samples 11 can pushthe previously acquired tissue samples 11 in the larger diameterproximal section 106 further proximally in the direction 105.

The internal face of the smaller diameter distal section 104 may havesurface features, such as the internal tissue-engaging features shown inFIG. 9, FIG. 10 and FIG. 22 a-g. A non-tapered tube can be used wherethe tissue-engaging surface features on the internal face of the tube 10extend a portion of the length of the tube 10 from the distal end 12 ofthe tube 10, for example about 2.5 cm (1 in). The remainder of the tube10 can have an internal face or wall absent of surface features (e.g.,smooth or low friction). The tissue sample 11 can be urged proximallyuntil the tissue sample 11 reaches the section of the tube 10 absent ofthe tissue-engaging features. At this section absent of tissue-engagingsurface features, the tissue sample 11 may no longer rotate with thetube 10. At this point, the tissue sample 11 may no longer spin, andthus not be urged proximally by the relative rotation of helical element32 and the tube 10. The section of the tube 10 absent of thetissue-engaging features may be coated with a lubricious material, suchas PTFE or Parylene. Thus, although the tissue sample 11 may be incontact with the tube 10, the tube face may not transmit sufficienttorque to rotate the tissue sample 11. The helical element 32 may have alow-friction coating for only the distal end, for example for about 2.5cm (1 in) from the distal end 12. Proximal to the low-friction section,the friction on the helical element 32 may be sufficiently large toprevent the tissue sample 11 from advancing in the direction 105 as thetube 10 spins.

The tool 5 may be configured to be side-cutting, as in FIG. 19 a andFIG. 19 b. The tool 5 can have a tissue acquisition system. The tissueacquisition system can be the open port 31 at the distal end 12 and thesurrounding edge (e.g., as shown and described in FIG. 2, FIG. 3, FIG.11, FIG. 12, FIG. 13 and elsewhere), a side port (e.g., a window 116)and the internal transport tube 10, or combinations thereof. An externaltube 110 can have a closed distal end 114. The closed distal end 114 canbe sharpened, for example, for low-resistance insertion and manipulationthrough the tissue 48. The external tube 110 can have the window 116proximal to the closed distal end 114. The transport tube 10 may belocated concentrically and/or radially internally within the externaltube 110, such that the transport tube 10 can move freely with respectto the external tube 110 but have a radial clearance larger than about0.02 mm (0.001 in), more narrowly larger than about 0.1 mm (0.004 in),yet more narrowly larger than about 0.2 mm (0.008 in), yet more narrowlylarger than about 0.3 mm (0.012 in), or yet more narrowly larger thanabout 0.4 mm (0.015 in). The radial clearance between the internaltransport tube 10 and the external tube 110 can be smaller than about0.4 mm (0.015 in), more narrowly smaller than about 0.3 mm (0.012 in),yet more narrowly smaller than about 0.2 mm (0.008 in), yet morenarrowly smaller than about 0.1 mm (0.004 in), or yet more narrowlysmaller than about 0.002 mm (0.001 in).

FIG. 19 a shows that the transport tube 10 can partially block thewindow 116. The window 116, may be open prior to sample acquisition,allowing the tissue 48 to enter the tool 5. The tool 5 can be pressedinto the targeted portion of tissue 48 so that the tissue sample 11 canenter the external tube 110 via the window 116. A vacuum may be appliedto draw the tissue through the window 116. To detach or sever the tissuesample 11, the transport tube 10 and the internal helical element 32 canbe advanced forward with respect to the external tube 110 and the tissuesample 11. The transport tube 10 can be rotated or spun whiletranslating with respect to the external tube 110 and the tissue sample11. The helical element 32 may be rotationally stationary relative tothe handle 6. The helical element 32 may be stationary relative to thehandle 6.

FIG. 19 b shows the tool with the window 116 closed, for example duringinsertion and/or tissue sample severing (e.g., partoff), and/or tissuesample 11 transport (e.g., translation proximally along the length ofthe transport tube 10). While the transport tube 10 spins, the tissuesample 11 can be urged proximally, as the tissue sample 11 may engagewith the internal helical element 32 and the internal transport tube 10,as described elsewhere herein.

FIG. 20 shows that the transport tube 10 may spin in a direction 9relative to the helical element 32. The helical element 32, withsharpened distal end 44, may be stationary or spin at a different speedthan the transport tube 10 in the same or opposite direction as thetransport tube 10. For example, the transport tube 10 can becounter-rotated with respect to the helical element 32 to advance asupplemental device or component (e.g., a tissue marker) or therapy(e.g., liquid or solid pharmacological agents), or combinations thereof,along the transport tube 10 to the target site of tissue 48. The tissuesample 11 can be from about 5 mm (0.2 in.) to about 25 cm (9.8 in.),more narrowly from about 1 cm (0.4 in.) to about 4 cm (1.6 in.), forexample about 2 cm (0.8 in.) long. The clearance gap 61 can be the spacebetween the radial inner surface 169 of the external outer element, forexample transport tube 10, and the external diameter of the innerinternal element, for example helical element 32 or curved stationaryelement 86.

The inner lumen 139 of the transport tube 10 may have a luminalcross-sectional area, for example about 5 mm² (0.0078 in²). The tissueengaging second element, such as the helical element 32, can have aninner element cross-sectional area, for example about 0.13 mm² (0.0002in²). The inner element cross-sectional area can be less than about 15%,more narrowly less than about 5%, for example about 2.5% of the luminalcross-sectional area.

FIG. 21 a, FIG. 21 b and FIG. 21 c illustrate that the distal end 12 ofthe tube 10 may be sharpened into a sharp cutting edge. The sharpcutting edge of the distal end 12 may be formed by sharpening theoutside diameter of the tube 10, as illustrated in FIG. 21 a. The sharpcutting edge of the distal end 12 may be formed by sharpening the insidediameter of the tube 10, as illustrated in FIG. 21 c. The sharp cuttingedge may be formed by sharpening both the inside and outside diametersof the tube 10. The sharpened cutting edge can have one or more cuttingedge angles 136, 138, 140, 142. The cutting edge angles 136, 138, 140 or142 may be larger than about 5 degrees, more narrowly larger than about15 degrees, yet more narrowly larger than about 25 degrees, yet morenarrowly larger than about 35 degrees, for example about 45 degrees. Thecutting edge angles 136, 138, 140, 142 may be smaller than about 45degrees, more narrowly smaller than about 35 degrees, yet more narrowlysmaller than about 25 degrees, yet more narrowly smaller than about 15degrees, or yet more narrowly smaller than about 5 degrees. The distalend 12 may be comprised of distal angle 138 and proximal angle 140. Thedistal angle 138 may be larger than the proximal angle 140.

The handle 6 can have the button 22, the motor 34 and the electricalconnection 18. A disposable assembly, which can include thetissue-engaging outer element, the tissue-engaging inner element and thecollection chamber 26 or a reservoir within the collection chamber 26,or combinations thereof, may then detachably connect mechanically to thereusable handle. The elements of the disposable assembly may be attachedor not attached to each other. The disposable assembly may be sterile.The disposable assembly may provide a barrier between the sterile andnon-sterile fields, while allowing the operator to actuate the button 22and the tissue-engaging outer element to engage with the motor 34. Afteruse, the disposable assembly may be disconnected and disposed of in anappropriate fashion. The reusable assembly may be uncleaned, may bewiped down between use, may be sterilized or resterilized, or anycombination thereof.

The helical element 32 as disclosed throughout herein may be replacedwith any of the tissue-engaging second elements, tissue-engaging innerelements, inner element and vice versa. The transport tube 10 asdisclosed throughout herein may be replaced with any of thetissue-engaging first elements, tissue-engaging outer elements, outerelement and vice versa.

FIG. 22 a through FIG. 22 g show variations of an internal surfacefeature on the transport tube 10. The internal surface features, forexample detent 168 and/or ribbon 170 and/or overlapping edge 174 and/ortraction tab edge 180, can increase torsional traction (e.g., deliverrotational force) between the tissue sample 11 and the transport tube10. The internal surface feature may not significantly impact traction(e.g., delivering no longitudinal force and providing minimal or nocounter force in the longitudinal direction) in the longitudinaldirection between the tissue sample 11 and the internal surface feature.Transport tube 10 may have a detent 168, as illustrated in FIG. 22 a.Detent 168 may be formed by stamping, rolling, extrusion, or anycombination thereof. The inner radial surface 169 at the detent 168 mayprotrude into the radially inner circular cross-section of the transporttube 10. The detent 168 may thus provide increase torsional fractionwith the tissue sample 11, when the tissue sample 11 is in the innerlumen. Detent 168 may protrude less than about 0.3 mm (0.012 in) intothe radially inner circular cross-section of the transport tube 10, ormore narrowly less than about 0.2 mm (0.008 in), for example about 0.1mm (0.004 in). The detent 168 may extend part or the entire length ofthe transport tube 10. Multiple detents 168 may be present along thelength and/or circumference of the inner radial surface 169.

FIG. 22 b illustrates that a flat wire 170 may be secured to the innersurface 169 of the transport tube 10. The ribbon 170 may be a section offlat wire or an arc section of a different tube that has been cut. Theribbon 170 may conform to the profile of the inner surface of thetransport tube 10. The ribbon 170 may be secured to the transport tube10 by welding, brazing, glue, or combinations thereof. A ribbonthickness 171 may be less than about 0.3 mm (0.012 in) thick, or morenarrowly less than about 0.2 mm (0.008 in) thick, for example about 0.1mm (0.004 in) thick.

FIG. 22 c illustrates that the transport tube 10 may be cut and bentcreating an overlapping section 172. The overlapping section 172 maycreate an overlapping edge 174 on the inner surface of the transporttube 10. The overlapping section 172 may be secured by welding, brazing,gluing, friction, interlocking tabs, or any combination thereof. Theoverlapping edge 174 may provide high friction or traction against atissue sample in the inner lumen when the tube 10 is rotated in a firstrotational direction with respect to the longitudinal axis, and lowfriction or fraction against the tissue sample when the transport tube10 is rotated in a second direction, opposite the first direction, withrespect to the longitudinal axis. For example, the overlapping edge maytransfer torque to the tissue sample 11 when the transport tube 10 isrotated clockwise, but not when the transport tube 10 is rotatedcounter-clockwise.

FIG. 22 d illustrates that an overlapping tube 176 may be pressed intothe transport tube 10. The transport tube 10 may be of an appropriatestiffness to maintain a circular cross-section while constraining theoverlapping section 172. For example, the overlapping section 172 may beformed by radially the overlapping tube 176. This overlapping tube 176may exert a radial force in the opposite direction to counter thecompression. This force may secure the overlapping tube 176 in thetransport tube 10, for example with friction. The transport tube 10 maybe stiff enough to maintain a circular cross-section while exposed tothis force.

FIG. 22 e illustrates that the distal end of the overlapping tube 176may be proximal to the terminal distal end 12 of the transport tube 10.The overlapping tube 176 may have a sharp distal edge similar to theterminal distal end 12, for example as illustrated in FIGS. 21 a through21 c. The distal end of the overlapping tube 176 may extend past or beflush with the terminal distal end 12. The distance between the distalend of overlapping tube 176 and distal end 12 may be larger than about0.5 mm (0.02 in), yet more narrowly larger than about 1 mm (0.04 in),yet more narrowly larger than about 1.5 mm (0.06 in), yet more narrowlylarger than about 2 mm (0.08 in), yet more narrowly than about 2.5 mm(0.10 in), yet more narrowly larger than about 3 mm (0.12 in), yet morenarrowly larger than about 3.5 mm (0.14 in), yet more narrowly largerthan about 4 mm (0.18 in), yet more narrowly larger than about 4.5 mm(0.18 in), yet more narrowly larger than about 5 mm (0.20 in), yet morenarrowly larger than about 6 mm (0.24 in), yet more narrowly larger thanabout 7 mm (0.28 in).yet more narrowly larger than about 10 mm (0.39in). The distance between the distal end of overlapping tube 176 anddistal end 12 may be less than about 10 mm (0.39 in), yet more narrowlyless than about 7 mm (0.28 in), yet more narrowly less than about 6 mm(0.24 in), yet more narrowly less than about 5 mm (0.20 in), yet morenarrowly less than about 4.5 mm (0.18 in), yet more narrowly less thanabout 4 mm (0.18 in), yet more narrowly less than about 3.5 mm (0.14in), yet more narrowly less than about 3 mm (0.12 in), yet more narrowlyless than about 2.5 mm (0.10 in), yet more narrowly less than about 2 mm(0.08 in), yet more narrowly less than about 1.5 mm (0.06 in), yet morenarrowly less than about 1 mm (0.04 in), yet more narrowly less thanabout 0.5 mm (0.02 in).

FIG. 22 f illustrates that a traction tab 178 may be formed on the sideof the transport tube 10. The transport tube 10 may have one or moretraction tabs 178. The traction tab 178 may extend the entire length ofthe transport tube 10 or for a section of the transport tube 10. A longtraction tab 178 may decrease the stiffness of the transport tube 10.Multiple traction tabs 178 may provide sufficient traction withoutsignificantly impacting the stiffness of the transport tube 10. Ifmultiple tabs are formed, they may be overlapped, as illustrated. Forexample, traction tabs 178 a and 178 b may overlap.

FIG. 22 g illustrates that the traction tab 178 can be a terminalangular end of a length of a longitudinally cut transport tube 10. Thetraction tab 178 can be radially inside the opposite terminal angularend of the transport tube 10. The traction tab 178 can press radiallyoutward against the radially inner surface of the opposite terminalangular end of the transport tube 10. The traction tab 178 can be bentto hold its shape so that it does not press radially outward against theradially inner surface of the opposite terminal angular end of thetransport tube 10. The Traction tab 178 can have a traction tab edge180. The traction tab edge 180 may create an elongated ridge fortransmitting torque to tissue sample 11. Traction tab 178 can be formedby stamping the metal (e.g., shearing), laser cutting, machining, wireEDM, chemical etching, or any combination thereof.

FIG. 23 a illustrates the tissue sample 11 can have a continuouselongated configuration. The tissue sample 11 can have a tissue samplelength 184 from about 0.5 cm (0.2 in) to about 4 cm (1.6 in), morenarrowly from about 1 cm (0.4 in) to about 3 cm (1.2 in), for exampleabout 2 cm (0.8 in).

FIG. 23 b illustrates that the tissue sample 11 can have a circularcross-section along all or part of the length of the tissue sample 11.The cross-section of the tissue sample 11 can vary along the length ofthe tissue sample 11, for example from anatomical variations along thelength of the tissue sample 11. The cross-section of the tissue sample11 can have a continuous profile (i.e., the cross-section can have noholes or deformations entirely within the perimeter of thecross-section). The cross-section of the tissue sample 11 can be simplyconnected or 1-connected. A space can be simply connected or 1-connectedif it is path-connected and every path between two points can becontinuously transformed, staying within the space, into any other pathwhile preserving the two endpoints in question.

The tissue sample can have a tissue sample diameter 186 from about 1 mm(0.04 in) to about 6 mm (0.24 in), more narrowly from about 2 mm (0.08in) to about 4 mm (0.16 in), for example about 3 mm (0.12 in).

FIG. 24 a illustrates that the inner lumen 139 can be the volume boundedor defined by the inner perimeter or inner diameter or radial innersurface of the external or outer element. For example, the inner lumen139 can be the volume bounded by transport tube 10 and any surfacefeatures, such as an overlapping tube and/or ribbon and/or rib and/orspiral rib, located on the radial inner surface of the transport tube10.

FIG. 24 b illustrates that the inner lumen 139 can have or contain atransport channel 133 and the tissue-engaging inner element (e.g.,helical element 32). The inner diameter of the inner element can definea transport cylinder 137 within the transport channel 133. During use,the tissue sample 11 can transport along the transport channel 133. Thetransport cylinder 137 can be an uninterrupted, open volume. Thetransverse cross-section of the transport cylinder 137 can be acontinuous profile (i.e., the cross-section can have no holes ordeformations entirely within the perimeter of the cross-section). Thetransverse cross-section of the transport cylinder 137 can be simplyconnected.

The transport channel 139 can have a transport channel length 188. Thetransport cylinder 137 can have a transport cylinder length 190. Thetransport channel length 188 can be equal to or greater than thetransport cylinder length 190. The transport cylinder length 190 can besmaller than, equal to or greater than an external element length 39.The transport channel 133 and transport cylinder 137 can extend alongpart or all of the length of the inner lumen 139.

The axis 8 of the transport tube 10 can be radially inside of thetransport cylinder 137. The transport channel 133 and/or the transportcylinder 137 can have a diameter from about 1 mm (0.04 in) to about 6 mm(0.24 in), more narrowly from about 2 mm (0.08 in) to about 4 mm (0.16in), for example about 3 mm (0.12 in).

The transport tube 10 can have surface features, such as the detent 168,the ribbon 170, the overlapping edge 174 and the fraction tab edge 180or combinations thereof. An elongated ridge parallel with a longitudinalaxis may be a surface feature, for example the detent 168, the ribbon170, the overlapping edge 174, the traction tab edge 180 or anycombination thereof.

It is apparent to one skilled in the art that various changes andmodifications can be made to this disclosure, and equivalents employed,or combinations of any of the disclosed elements, characteristics,features, devices, tools, steps, or methods without departing from thespirit and scope of the invention. Any of the disclosed elements,characteristics, features, devices, tools, steps, or methods can bepresent as a singular or as a plurality regardless of whether theelements, characteristics, features, devices, steps, or methods areexplicitly disclosed herein as being singular or as a plurality.Elements shown with any variation are exemplary for the specificvariation and can be used on other variation within this disclosure.

1. A tool for acquiring a tissue comprising: a handle; a tissue-engagingouter element comprising a substantially tubular structure; and atissue-engaging inner element located at least partially within thetissue-engaging outer element; wherein the tissue-engaging outer and/orinner element comprises a helical feature; and wherein the tool isconfigured such that relative rotation between the tissue-engaging outerelement and the tissue-engaging inner element urges the tissue in anaxial direction, and wherein the tissue-engaging inner element isconfigured to be rotationally fixed with respect to the handle.
 2. Thetool of claim 1, wherein the tissue-engaging outer element is rotatablewith respect to the handle; and wherein the terminal distal end of thetissue-engaging outer element is sharpened and configured to core thetissue mass when the tissue-engaging outer element rotates with respectto the tissue mass; and wherein the tissue-engaging inner elementcomprises a coiled wire having a circular cross-section.
 3. The tool ofclaim 1,wherein the tissue-engaging outer element has a radial innersurface, and wherein the radial inner surface has an elongated ridgeparallel with a longitudinal axis of the tissue-engaging outer element;and wherein the tissue-engaging outer element has an open first end andan open second end, and wherein the tissue-engaging outer element isconfigured to receive the tissue in the first end and deposit tissue outof the second end; and wherein the handle comprises a chamber, andwherein the chamber is configured to receive the tissue from the secondend.
 4. The tool of claim 1, wherein the tissue-engaging outer elementhas an open first end and an open second end, and wherein thetissue-engaging outer element is configured to receive the tissue in thefirst end and deposit the tissue out of the second end; and wherein thetool is configured to not apply suction to the second end.
 5. The toolof claim 1, wherein the tissue-engaging outer element has atissue-contacting first surface and the tissue-engaging inner elementhas a tissue contacting second surface, and wherein the first surfaceand/or the second surface comprise a surface feature.
 6. The tool ofclaim 1, wherein the tissue-engaging inner element is configured totransport a supplemental device or therapy distally and/or proximallyalong the tissue engaging outer element.
 7. The tool of claim 1, whereinthe tissue-engaging outer element has a tissue-engaging outer elementlength; and wherein the tissue-engaging outer element has a transportcylinder having a transport cylinder length, and wherein the transportcylinder length is equal to or greater than the tissue-engaging outerelement length.
 8. The tool of claim 3, wherein the elongated ridgecomprises an overlapping tube and/or a fraction tab.
 9. The tool ofclaim 1, wherein the tool is configured to provide access to a tissuesample at all times, including when the tool is configured to acquiretissue.
 10. A method for acquiring tissue at a tissue site comprising:positioning a tool in a mass at the tissue site, wherein the toolcomprises a tissue-engaging outer element, and a tissue-engaging innerelement located at least partially inside the tissue-engaging outerelement, wherein the tissue-engaging outer element or thetissue-engaging inner element has a helical feature; rotating thetissue-engaging outer element with respect to the mass; detaching atissue sample from the mass; receiving the tissue into thetissue-engaging outer element; forcing the tissue through thetissue-engaging outer element, wherein forcing comprises transportingthe sample with respect to the tissue-engaging outer element when thetissue-engaging outer element is positioned in the mass, whereintransporting further comprises rotating the tissue-engaging outerelement with respect to the tissue-engaging inner element, and whereintransporting further comprises rotating the tissue with respect to thehelical feature; and wherein transporting further comprises contactingthe sample with the tissue-engaging outer element; and holding thetissue-engaging inner element rotationally stationary with respect tothe mass of tissue.
 11. The method of claim 10, wherein the tissue isreceived in the first end of the tissue-engaging outer element anddeposited out of the second end; and wherein suction is not applied tothe second end.
 12. The method of claim 10, wherein the detached tissuerotates relative to the tissue-engaging inner element.
 13. The method ofclaim 10, wherein the tissue-engaging element comprises a coiled wirehaving a circular cross-section.
 14. The method of claim 10, wherein thetissue-engaging inner element is longitudinally stationary relative tothe tissue-engaging outer element.
 15. A method for removing a samplefrom a mass of tissue comprising: positioning a device in the mass,wherein the device comprises a tissue-engaging outer element and atissue-engaging inner element located at least partially inside thetissue-engaging outer element; and wherein the tissue-engaging innerelement is rotationally stationary with respect to the mass of tissue;and transporting the sample, wherein transporting comprises rotating thetissue-engaging outer element with respect to the tissue-engaging innerelement, and wherein transporting further comprises contacting thesample with the tissue-engaging outer element.
 16. The method of claim15, further comprising rotating the tissue-engaging outer element withrespect to the mass; and wherein the tissue-engaging outer elementcontacts the mass; and wherein the device comprises a handle, andwherein the tissue-engaging inner element is rotationally fixed withrespect to the handle; and wherein the tissue-engaging inner elementcomprises a helical coil.
 17. The method of claim 15, wherein thetransporting of the sample comprises transporting the sample into afirst end of the tissue-engaging outer element and out of a second endof the tissue-engaging outer element, and wherein the device comprises acollection chamber, and wherein the transporting of the sample furthercomprises transporting the sample from the second end of thetissue-engaging outer element to the collection chamber.
 18. The methodof claim 15, wherein the tissue is received in the first end of thetissue-engaging outer element and deposited out of the second end; andwherein suction is not applied to the second end.
 19. The method ofclaim 15, wherein the tissue engaging outer element has a transportcylinder having a transport cylinder length, and wherein the transportcylinder length is equal to or greater than the tissue-engaging outerelement length.
 20. The method of claim 15, further comprising removingthe sample from the device while the device is positioned in the mass.